GJA — Test, Thrombin Time Class II
FDA product code GJA covers "Test, Thrombin Time", a Class II medical device regulated under 21 CFR 864.7875. Submissions are reviewed by the Hematology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GJA
- Device Class
- Class II
- Regulation Number
- 864.7875
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K050817 | r2 diagnostics | T-TEK | December 12, 2005 |
| K982209 | sigma diagnostics | ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589 | October 15, 1998 |
| K970645 | behring diagnostics | BC THROMBIN REAGENT | May 19, 1997 |
| K925493 | biomerieux vitek | BIOMERIEUX HEMOLAB THROMBICALCI-TEST | April 21, 1994 |
| K930157 | behring diagnostics | TEST THROMBIN | May 14, 1993 |
| K923220 | medical laboratory automation systems | THROMBIN CLOT TIME TEST PROCEDURE | September 29, 1992 |
| K920147 | helena laboratories | THROMBIN CLOTTING TIME REAGENT | May 1, 1992 |
| K900126 | international technidyne | TT AND HNTT BY HEMOCHRON | February 5, 1990 |
| K894467 | sigma chemical | THROMBIN TIME REAGENT | September 5, 1989 |
| K884384 | american bioproducts | THROMBIN-PREST REAGENT KIT | December 28, 1988 |
| K884385 | american bioproducts | FIBRI-PREST/THROMBIN-PREST CONTROLS | December 28, 1988 |
| K862301 | instrumentation laboratory | IL SYSTEM 810, ACL AND THE REAGENT SETS | September 3, 1986 |
| K845000 | bio/data | THROMBINEX BOVINE THROMBIN | March 26, 1985 |
| K841956 | haemachem | BOVINE THROMBIN, HUMAN THROMBIN | July 19, 1984 |
| K834301 | bio/data | THROMBOLYTIC ACTIVITY TEST | February 4, 1984 |
| K822466 | american dade | THROMBIN TIME TEST | September 14, 1982 |
| K811109 | bio/data | THROMBIN CLOTTING TIME | July 16, 1981 |
| K802117 | general diagnostics | FIBRI QUIK | September 26, 1980 |
| K800926 | general diagnostics | THROMBOQUIK THROMBIN REAGENT PROD. #3551 | May 8, 1980 |
| K781781 | general diagnostics | HEPARSORB | January 10, 1979 |